QA Specialist I - Supplier Quality

PCI Pharma Services • Bedford, NH

1d • Onsite

About The Position

This position is part of PCI’s Quality Compliance team responsible for the quality aspects of supplier quality management for suppliers that provide raw materials, components, contract test labs and services for GMP operations. The position is responsible for ensuring all aspects of the Supplier Qualification program are successfully executed across all PCI facilities.

Requirements

• Bachelor of Science Degree preferred with 3+ years’ in a QA GMP environment; High School diploma with 5+ years’ of progressive experience in QA GMP environment considered.
• Ability to articulate and comprehend industry related technical subject matter.
• Exceptional organizational skills.
• Excellent interpersonal skills and the ability to communicate well orally and in writing.
• Proficiency in MS Office including Word, Excel.
• Experience working with cross-functional teams.
• Detail oriented and a results-driven team player.
• Honesty, integrity, respect and courtesy with all colleagues.

Nice To Haves

• Experience with GMP quality systems in a pharmaceutical/biotech/medical device environment is preferred.
• Familiarity with regulatory guidance (i.e., FDA 21CFR Part 210, 211 & 820; EMA), and ICH is preferred.

Responsibilities

• Responsible for follow up and tracking of supplier audit observations to ensure timely closure.
• Monitor and communicate supplier change notifications and manage supplier non-conformance and complaint handling.
• Responsible for reviewing all audit responses to assure non-recurrence of deficiencies.
• Drafting, review and management of supplier quality assurance agreements (QAA’s) and non-disclosure agreements.
• Collaborate with Corporate Supplier Quality team members; align on Supplier Qualification program initiatives, report status of site-specific Supplier Qualification actions.
• Support Supplier Risk Assessments.
• Support Annual Product Quality Review’s.
• Support Quality System events impacting the Supplier Quality program.
• Request, reconcile, and file Supplier Qualification documentation.
• Provide support for Quality Council meetings.
• Writes and revises Standard Operating Procedures (SOP).
• Support continuous improvement initiatives.
• Performs other duties as assigned.

Benefits

• At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level